Serum and Salivary Cortisol Assessment in Patients With Adrenal Incidentalomas and Healthy Controls (SALICOR)

January 16, 2026 updated by: Nanna Thurmann Jørgensen, Rigshospitalet, Denmark

Cortisol Assessment in Patients With Adrenal Incidentalomas

The goal of this observational study is to evaluate the diagnostic accuracy of salivary cortisol compared with serum cortisol after a 1 mg overnight dexamethasone suppression test in participants (N = 100) with adrenal incidentalomas and healthy control participants (N = 100). The main question it aims to answer is:

Are salivary cortisol and serum cortisol equal diagnostic tools for endogenous hypercortisolism?

The inclusion of healthy controls will serve as a reference population to define the central 95 % reference interval for the serum and salivary cortisol levels.

Participants will undergo routine medical examination of adrenal incidentalomas including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The patient group were patients newly diagnosed with an adrenal incidentaloma and referred to either the Department of Nephrology and Endocrinology, Copenhagen University Hospital, Rigshospi-talet, Denmark or Department of Medicine, Copenhagen University Hospital Herlev Gentofte, Herlev, Denmark.

The controls were recruited through social media, online participant recruitment platform , the hospital website, and physical posters in public spaces around Copenhagen, Denmark.

Description

Inclusion Criteria (patients):

  • age ≥ 18 years, a new diagnosis of an adrenal incidentaloma (defined as an adrenal mass > 1 cm detected when using diagnostic imaging for non-related reasons).

Inclusion Criteria (controls):

  • age ≥ 18 years, no previous history of conditions involving the adrenal glands

Exclusion Criteria (patients):

  • active cancer; an adrenal incidentaloma suspected of malignancy; bilateral adrenal incidentalomas; pregnancy and breastfeeding; conditions or medical treatments that interfere with dexamethasone metabolism and cortisol metabolism/measurements; severe comorbidities; chronic kidney disease (defined as an estimated glomerular filtration rate < 60 ml/min); and inability to provide written informed consent.

Exclusion Criteria (controls):

  • active cancer; pregnancy and breastfeeding; conditions or medical treatments that interfere with dexamethasone metabolism and cortisol metabolism/measurements; severe comorbidities; chronic kidney disease (defined as an estimated glomerular filtration rate < 60 ml/min); and inability to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy control group
Diagnostic test: 1 mg overnight dexamethasone suppression test
Included participants will undergo routine medical examination including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol.
Patients with adrenal incidentalomas
Diagnostic test: 1 mg overnight dexamethasone suppression test
Included participants will undergo routine medical examination including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cortisol and cortisone in patients and controls following an overnight dexamethasone suppression test
Time Frame: Baseline (Day 0, 08:00-09:00 hour) and post-dexamethasone (Day 1, 08:00-09:00 hour)
Cross-sectional evaluation of serum and salivary cortisol and cortisone after an overnight 1 mg dexamethasone suppression test in patients with adrenal incidentalomas and healthy controls.
Baseline (Day 0, 08:00-09:00 hour) and post-dexamethasone (Day 1, 08:00-09:00 hour)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Copenhagen University Hospital at Herlev

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2016

Primary Completion (Actual)

April 26, 2024

Study Completion (Actual)

April 26, 2024

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16041718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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